A Pilot Study to Develop a Technique for External Beam Radiotherapy After Radical Prostatectomy Based on MRI-Delineation of the Clinical Target Volume
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- To develop a technique for MRI-delineation of the clinical target volume (CTV) for EBRT following radical prostatectomy
研究概览
简要总结
Delivery of conformal radiation therapy following radical prostatectomy is limited by the inability to define the clinical target volume (CTV). This stems from a poor understanding of patterns of local recurrence and limitations of standard imaging techniques.Magnetic Resonance Imaging (MRI) is a promising modality for imaging the prostatic bed following radical prostatectomy. MRI provides more detailed postoperative anatomy to guide CTV delineation, the ability to document local recurrence patterns, and a method to assess intrafraction prostatic bed motion and deformity to define appropriate planning target volume margins. The aim of this pilot study is to develop a technique for external beam radiation therapy (EBRT) following radical prostatectomy based on MRI-delineation of the CTV. Twenty patients will be enrolled in this pilot, development phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients following radical prostatectomy for prostate adenocarcinoma with one or more of the following adverse features:
- •pT2 + positive surgical margins ) pT3 ) PSA ≤ 2ng/ml Persistently elevated PSA at 3 months )
- •Patients with initially undetectable PSA following prostatectomy for prostate adenocarcinoma with subsequent PSA relapse
- •Patients being planned for radiation therapy
- •No evidence of distant metastases
- •Age ≥ 18 years
- •ECOG performance status 0 or 1
- •Informed consent
排除标准
- •Contraindications to MRI Patients weighing >136 kgs (weight limit for the scanner tables) Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices not compatible with MRI.
- •Severe claustrophobia
- •Inflammatory bowel disease or collagen vascular disease
- •Previous colorectal surgery
- •Previous pelvic radiotherapy
研究组 & 干预措施
External Beam Radiation Therapy
干预措施: External Beam Radiotherapy (Procedure)
结局指标
主要结局
To develop a technique for MRI-delineation of the clinical target volume (CTV) for EBRT following radical prostatectomy
时间窗: After data acquisition
次要结局
- To explore the utility of IV contrast for the delineation of gross tumor recurrence and normal blood vessels.(After data acquisition)
- To compare the reproducibility of clinical target volume and rectal wall volume delineation on MRI and CT.(After data acquisition)
- To compare the location of the urethral anastomosis defined on MRI as compared to a fiducial marker placed under TRUS-guidance adjacent to the anastomosis.(After data acquisition)
- To measure the amount of intrafraction movement and deformity of the prostatic bed and seminal vesicles with current bowel regimen of daily milk of magnesia using cinematic MRI.(After data acquisition)
- To determine the optimal radiation technique that encompasses the MRI-defined PTV whilst respecting bowel and bladder dose constraints.(After data acquisition)
- To measure the amount of interfraction movement and deformity of the bladder, rectum, and surgical clips within the operative bed using daily cone-beam CT imaging.(After data acquisition)